Five-year, nearly $90 million deal revolves around bulk drug substance formulation for Providence’s future shot
Emergent BioSolutions Inc., a life sciences company, and biotech firm Providence Therapeutics have entered into a five-year, approximately $90 million contract development and manufacturing (CDMO) services agreement that encompasses Emergent’s experience, consisting of development services, bulk drug substance formulation and drug product manufacturing, to support Providence’s Covid-19 messenger RNA (mRNA) vaccine development.
In 2022, Emergent will manufacture tens of millions of doses of PTX-COVID19-B drug product, Providence’s vaccine candidate, as well as batches of PTX-COVID19-B formulated bulk drug substance with the potential to yield hundreds of millions more doses.
Per the deal, Emergent will provide current good manufacturing practice (cGMP) manufacturing services for two presentations of PTX-COVID19-B, consisting of the formulated bulk drug substance and finished drug product (fill-finish), at Emergent’s facility in Winnipeg, MB, Canada. Further process and analytical development services will take place from Emergent’s Center of Excellence for Development Services in Gaithersburg, MD. The agreement covers manufacturing services and studies to support global supply chain activities, along with facility and equipment investments.
In response to the Covid pandemic, Emergent has partnered with various pharma and biotech companies, including Johnson & Johnson, in which it has been producing J&J’s vaccine bulk drug substance.
Understanding the FDA's Exemption for DSCSA Compliance
November 12th 2024In the quest for achieving full traceability, the exemption applies to certain trading partners under the Act, and postpones enforcement of final compliance requirements while acknowledging progress and ongoing challenges.